Hospira LifeCare PCA 3 User manual
System Operating Manual
Hospira, Inc., Lake Forest, IL 60045, USA
430-04684-002 (Rev. 01/06)
Change History
Title Description of Change
Pages
Affected
430-04684-001
(Rev. 1/05)
430-04684-002
(Rev. 01/06)
Initial Release All
Second Release All
430-04684-002 (Rev. 01/06)
LifeCare PCA 3 Infusion System i
Contents
1) DESCRIPTIVE INFORMATION . . . . . . . . . . . . . . . . 1-1
1.1 P
RODUCT DESCRIPTION . . . . . . . . . . . . . . . . . . . 1-1
NDICATIONS FOR USE . . . . . . . . . . . . . . . . . . . . . 1-2
1.2 I
patient selection . . . . . . . . . . . . . . . . . . . . . . . . 1-2
user qualification . . . . . . . . . . . . . . . . . . . . . . . . 1-3
1.3 C
ONTRAINDICATIONS FOR USE . . . . . . . . . . . . . . . 1-3
1.4 C
ONVENTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
warnings, cautions, and notes . . . . . . . . . . . . . . 1-4
1.5 D
EFINITIONS (GENERAL AND CLINICAL). . . . . . . . . 1-6
RECAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
1.6 P
artifacts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
general . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
programming . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
loading dose/dose limits . . . . . . . . . . . . . . . . . 1-11
operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
epidural administration . . . . . . . . . . . . . . . . . . 1-13
battery operation . . . . . . . . . . . . . . . . . . . . . . . 1-14
sets and accessories . . . . . . . . . . . . . . . . . . . . 1-15
2) PRINCIPLES OF OPERATION . . . . . . . . . . . . . . . . 2-1
EATURES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
2.1 F
drug recognition . . . . . . . . . . . . . . . . . . . . . . . . 2-2
modes of delivery . . . . . . . . . . . . . . . . . . . . . . . 2-2
programming . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
bio medical . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
other features . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
2.2 A
DMINISTRATION EQUIPMENT . . . . . . . . . . . . . . . 2-4
administration sets . . . . . . . . . . . . . . . . . . . . . . 2-4
2.3 P
RINTER KITS . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
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3) EQUIPMENT DESCRIPTION . . . . . . . . . . . . . . . . . . 3-1
3.1 C
OMPONENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
3.2 O
PERATING BUTTONS & KEYS . . . . . . . . . . . . . . . 3-4
4) BASIC OPERATION . . . . . . . . . . . . . . . . . . . . . . . . 4-1
4.1 G
ETTING STARTED . . . . . . . . . . . . . . . . . . . . . . . 4-1
unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
connecting the patient pendant . . . . . . . . . . . . 4-1
system self-tests . . . . . . . . . . . . . . . . . . . . . . . . 4-2
data retention . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
PERATING THE PCA 3 . . . . . . . . . . . . . . . . . . . 4-3
4.2 O
intravenous
epidural
OADING VIAL . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
4.3 L
DJUSTING SETTINGS . . . . . . . . . . . . . . . . . . . . . 4-7
4.4 A
changing alarm volume . . . . . . . . . . . . . . . . . . . 4-8
changing contrast of main display . . . . . . . . . . . 4-9
changing or confirming time and date . . . . . . . . 4-9
4.5 G
UIDED START-UP FOR PREFILLED VIALS . . . . . . 4-12
purging the system . . . . . . . . . . . . . . . . . . . . . 4-13
loading dose. . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
4.6 G
UIDED START-UP FOR CUSTOM VIALS . . . . . . . 4-17
PCA administration . . . . . . . . . . . . . 4-3
PCA administration . . . . . . . . . . . . . . . . 4-4
5) SELECT MODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5.1 M
ODES OF DELIVERY . . . . . . . . . . . . . . . . . . . . . 5-1
protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
PCA only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
continuous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
PCA+continuous . . . . . . . . . . . . . . . . . . . . . . . . 5-2
ROGRAMMING PCA ONLY . . . . . . . . . . . . . . . . . 5-3
5.2 P
5.3 C
ONTINUOUS MODE . . . . . . . . . . . . . . . . . . . . . . 5-7
5.4 PCA + C
ROTOCOLS . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16
5.5 P
5.6 D
OSE LIMIT (1 OR 4 HOUR) . . . . . . . . . . . . . . . . 5-18
ONTINUOUS MODE . . . . . . . . . . . . . . . 5-10
dose limit calculation . . . . . . . . . . . . . . . . . . . . 5-18
programming the 4 (or 1) hr dose limit. . . . . . . 5-20
to program a dose limit . . . . . . . . . . . . . . . . . . 5-20
to program
NO dose limit . . . . . . . . . . . . . . . . . 5-21
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to clear or change dose limit . . . . . . . . . . . . . . 5-22
clearing the history & Rx settings. . . . . . . . . . . 5-23
5.7 U
SING REVIEW SCREENS . . . . . . . . . . . . . . . . . . 5-24
HANGING SETTINGS DURING SETUP . . . . . . . . 5-25
5.8 C
5.9 S
TOPPING INFUSION OR TURNING PUMP OFF . . . 5-26
5.10 M
5.11 C
5.12 P
5.13 P
5.14 D
5.15 H
6) TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . 6-1
6.1 S
6.2 P
6.3 S
6.4 A
AKING CHANGES AFTER SETUP . . . . . . . . . . 5-27
to review current settings . . . . . . . . . . . . . . . . 5-27
to change settings . . . . . . . . . . . . . . . . . . . . . . 5-28
to clear shift totals . . . . . . . . . . . . . . . . . . . . . . 5-29
to change a vial . . . . . . . . . . . . . . . . . . . . . . . . 5-30
to add a supplemental loading dose . . . . . . . . 5-32
HECKING HISTORY & SETTINGS . . . . . . . . . . . 5-33
RINTER SETUP . . . . . . . . . . . . . . . . . . . . . . . . 5-34
RINTING EVENT HISTORY LOG . . . . . . . . . . . . 5-39
OWNLOADING TO A PC. . . . . . . . . . . . . . . . . . 5-40
ISTORY AND EVENT LOG . . . . . . . . . . . . . . . . 5-43
TATUS MESSAGES . . . . . . . . . . . . . . . . . . . . . . 6-1
UMP ALARM SYSTEM . . . . . . . . . . . . . . . . . . . . . 6-2
ILENCING AN ALARM . . . . . . . . . . . . . . . . . . . . . 6-3
LARMS AND MESSAGES . . . . . . . . . . . . . . . . . . . 6-4
7) MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
7.1 P
UMP STORAGE . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
LEANING AND SANITIZING . . . . . . . . . . . . . . . . . 7-1
7.2 C
ATTERY MAINTENANCE . . . . . . . . . . . . . . . . . . . 7-3
7.3 B
service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
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8) SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
8.1 S
TORED OCCLUSION VOLUME . . . . . . . . . . . . . . . 8-4
8.2 T
IME FROM OCCLUSION TO ALARM . . . . . . . . . . . . 8-4
ELIVERY RATE ACCURACY . . . . . . . . . . . . . . . . . 8-4
8.3 D
trumpet curves . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
example . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
8.4 T
RUMPET CURVES . . . . . . . . . . . . . . . . . . . . . . . . 8-7
9) PRESCRIPTION DELIVERY LIMITS . . . . . . . . . . . . 9-1
10) WARRANTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
© Hospira, Inc. All Rights Reserved
This document and the subject matter disclosed herein are proprietary
information. Hospira retains all the exclusive rights of dissemination,
reproduction, manufacture and sale. Any party using this document
accepts it in confidence, and agrees not to duplicate it in whole or in
part nor disclose it to others without the written consent of Hospira.
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LifeCare PCA 3 Infusion System 1- 1
1) Descriptive Information
The LifeCare® PCA 3TM Infusion System is the newest Hospira
LifeCare
PCA 3 system can be used in a wide range of clinical settings,
including but not limited to:
®
PCA device. Like its predecessor, the PCA Plus II, the
General Floor Labor/Delivery/
Post Partum
Medical/Surgical Operating Room Oncology
Critical Care
Units
The PCA 3 Infusion pump allows clinicians to administer or
patients to self-administer, analgesia safely and effectively within
clinician programmed limits. The epidural route can be used to
provide anesthesia or analgesia.
Post Anesthesia
Care Unit (PACU)
Burn Unit
Pediatrics
1.1 Product Description
The primary feature of the PCA 3 is the bar code reader, which is
designed to automate drug identification. Other enhancements
include new programming features, a numeric keypad to directly
enter programming values, and a device weight of less than 12
pounds.
The PCA 3 system includes a microprocessor based infusion
device with keypad controls, patient pendant, a bar coded drug
vial, and a compatible administration set (see Section 2.3 for list
of compatible sets). The pump has a serial port for connection to
a computer or printer, and the software is field upgradeable. It is
intended to operate on AC power, but an internal battery is
provided to maintain operation for short periods of time when AC
power is not available.
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1- 2 1) Descriptive Information
The vials are single-use, bar coded and prefilled with a
prescription drug by
filled by the hospital pharmacy.
The PCA 3 system is capable of the following modes of delivery:
Hospira, or sterile and empty to be custom-
• PCA ONLY
• CONTINUOUS ONLY
• PCA+CONTINUOUS
The PCA 3 system also provides the ability to store frequently
used prescriptions called Protocols. The protocols are only
available for
the service mode by a hospital-designated authority.
Hospira pre-filled vials and must be set up through
1.2 Indications for Use
PCA is a method of pain management that permits patients to
treat their pain by self-administering doses of analgesics. PCA
can be used to manage all types of pain, but is most commonly
used to manage acute pain.
PATIENT SELECTION
Patients selected for use of PCA should be able to understand
the relationship between pain, pushing the PCA patient pendant
and pain relief, and can physically self-administer a PCA dose
using the patient pendant.
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WARNING
FOR EPIDURAL USE, ADMINISTER ONLY
ANESTHETICS/ANALGESICS APPROVED FOR
EPIDURAL ADMINISTRATION (AS INDICATED OR
ALLOWED BY THE DRUGS’ FDA APPROVED
LABELING). EPIDURAL ADMINISTRATION OF DRUGS
OTHER THAN THOSE INDICATED FOR EPIDURAL
USE COULD RESULT IN SERIOUS INJURY TO THE
PATIENT.
USER QUALIFICATIONS
All clinicians should be appropriately trained on programming of
the PCA 3 pump prior to use.
The PCA 3 is intended for use at the direction or under the
supervision of licensed physicians or certified healthcare
professionals. They must be trained in the use of the pump,
administration of parenteral and epidural fluids and drugs, and
the prevention of related IV complication and precautions to
prevent accidental infusion of air. Training should emphasize the
assessment and monitoring of patients receiving potent analgesic
medications, and the appropriate treatment for possible adverse
reactions.
1.3 Contraindications For Use
The PCA 3 should not be used for patient controlled analgesia by
patients who do not have the cognitive ability to understand the
use of self-administered pain medication nor have the physical
capacity to operate the patient pendant, if required.
Drugs not compatible with silicone rubber or PVC plastic, or not
stable under infusion conditions, should not be used with this
system.
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1- 4 1) Descriptive Information
1.4 Conventions
This section describes the conventions used throughout this
manual, as follows:
CONVENTION APPLICATION EXAMPLE
Italic Reference to a
section, figure, or
table
Function or mode
specific
instructions
[BRACKETED
ALL-CAPS]
ItalicSmallcaps> Softkey Options C
Initial Caps
lowercase
Bold Emphasis ...sets are
Keys or buttons
on the device are
displayed in
[BRACKETED
ALL-CAPS] or
with a graphic.
Screen displays
and device labels
(as appropriate)
(See Section 3-1,
Components)
Primary Only:
Attach an empty
container.
[START/PAUSE]
or
HOOSE>
Therapy
Dose Calculation
supplied Sterile
and are for....
WARNINGS, CAUTIONS, AND NOTES
Alert messages used throughout this manual are described
below. Pay particular attention to these messages.
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LifeCare PCA 3 Infusion System 1- 5
WARNING
A WARNING MESSAGE CONTAINS SPECIAL SAFETY
EMPHASIS AND MUST BE OBSERVED AT ALL TIMES.
FAILURE TO OBSERVE A WARNING MESSAGE IS
POTENTIALLY LIFE THREATENING.
CAUTION: A
PROCEDURE
PREVENT IRREVERSIBLE PRODUCT DAMAGE OR
COULD
HARDWARE
COULD RESULT IN SERIOUS PATIENT OR USER INJURY.
CAUTION USUALLY APPEARS IN FRONT OF A
OR STATEMENT. IT CONTAINS INFORMATION THAT
FAILURE. FAILURE TO OBSERVE A CAUTION
NOTE: A Note highlights information that helps explain a
concept or procedure.
This symbol directs the user to consult accompanying
documents.
NOTE: Figures are rendered as graphic representations
to approximate the actual product. Therefore, figures
may not exactly reflect the product.
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1- 6 1) Descriptive Information
1.5 Definitions (General and Clinical)
TERM DEFINITION
1 Hour Dose Limit Programmed parameter specifying
the maximum amount of drug that
can be administered in a rolling
(continuously advancing) one hour
time period.
4 Hour Dose Limit Programmed parameter specifying
the maximum amount of drug that
can be administered in a rolling
(continuously advancing) four hour
time period.
Accuracy The degree to which the instrument
is capable of delivering the volume
of analgesic drug that is displayed
or targeted to be delivered.
Accuracy shall be specified as the
maximum allowable delivery error
from a targeted or displayed value
(see product specification, Section
9).
Continuous Infusion therapy characterized by a
constant fixed-rate dose.
Custom Syringe or
Vial
Default Generally refers to the factory
History Displays Parameter Settings, Dose
Bar coded Hospira sterile empty
vial which is custom-filled by a
licensed pharmacy.
setting for parameters or options.
History and Event Log. Also
provides access to Print History
softkey.
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LifeCare PCA 3 Infusion System 1- 7
TERM DEFINITION
Lockout Interval Programmed time interval
specifying the minimum time that
must pass after a PCA dose or
Loading Dose is administered
before the next PCA dose can be
infused. The bolus requests made
during this period are not delivered.
Loading Dose An optional dose delivered before
starting normal function of the
pump (or thereafter by unlocking
the door).
Occlusion Inability of the instrument to infuse
fluid to the patient. Possible causes
of occlusions include kinked
tubing, plugged tubing, etc.
Maximum
Occlusion Pressure
Patient Pendant Hand-held pendant connected to
PCA mode Infusion therapy characterized by
PCA 3 Vial Bar coded vial compatible with the
PCA 3 Instrument Programmable patient controlled
PCA 3 Set Tubing which connects the PCA 3
The maximum pressure observed in
response to a patient line
occlusion.
the instrument that allows the
patient to request a bolus PCA dose
by pressing a button.
bolus doses administered on
patient demand subject to a lockout
interval and, optionally, a 1 or 4
hour dose limit.
PCA 3 instrument that is either
prefilled or custom filled with a
drug.
infusion pump.
Vial to the patient.
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1- 8 1) Descriptive Information
TERM DEFINITION
Prime Manually removing air from the
syringe and line.
Purge Running the mechanism to remove
system slack when a new vial/
injector is installed. (The system
must be primed first and
disconnected from the patient.)
Warning An indication to advise the
clinician:
A) of a possible dangerous
condition such as a low battery
B) that an attempt has been made to
use a function in the wrong
sequence, wrong time, or with the
wrong values, such as an invalid
key attempt
1.6 Precautions
• Product damage may occur unless proper care is
exercised during the unpacking and setup process. The
battery may not be fully charged upon receipt.
ARTIFACTS
• Nonhazardous, low-level electrical potentials are
commonly observed when fluids are administered using
infusion devices. These potentials are well within
accepted safety standards, but may create artifacts on
voltage-sensing equipment such as ECG, EMG, and EEG
machines. These artifacts vary at a rate that is
associated with the infusion rate. If the monitoring
machine is not operating correctly or has loose or
defective connections to its sensing electrodes, these
artifacts may be accentuated so as to simulate actual
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LifeCare PCA 3 Infusion System 1- 9
physiological signals. To determine if the abnormality in
the monitoring equipment is caused by the infusion
device instead of some other source in the environment,
set the infusion device so that it is temporarily not
delivering fluid. Disappearance of the abnormality
indicates that it was probably caused by the electronic
noise generated by the infusion device. Proper setup and
maintenance of the monitoring equipment should
eliminate the artifact. Refer to the appropriate monitoring
equipment system documentation for setup and
maintenance instructions.
• The PCA 3 system is designed to operate normally in the
presence of most encountered electromagnetic
interference (EMI) conditions. In the event of extreme
levels of interference, such as those encountered next to
an electrosurgical generator, it is possible that the
normal operation of a sensor or microcomputer might be
disrupted. Even in this event, the outcome would likely
be a false alarm or detected system malfunction and
would not result in a hazard to patient or clinician.
• Use of radio frequency emitting devices such as cellular
telephones and 2-way radios in close proximity of this
device may affect its operation.
GENERAL
• Possible explosion hazard exists if used in the presence
of flammable anesthetics.
• Potent analgesic medications are used with this device.
Refer to drug package insert for precautions and
possible adverse reactions.
• Refer to analgesic package enclosure for possible
incompatibility with fluid or drug being delivered through
the IV line.
• Coupling together of more than one pump into one
patient line may significantly affect the infusion rate of at
least one of the pumps.
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1- 10 1) Descriptive Information
• Do not use sharp objects such as pens, scissors, or
fingernails to press keys. Such objects may damage
keys and cause a malfunction.
• Arrange tubing, cords, and cables to minimize the risk of
patient strangulation or entanglement.
• Failure to use Hospira vials and Hospira PCA sets with
integral anti-siphon valve may cause an inaccurate dose
delivery to the patient.
• The system must be primed prior to purging. Remove all
air from vial before placing into pump.
• Always close slide clamp on PCA administration set
before removing or replacing syringe, and before
discontinuing infusion.
• Patient must be disconnected from the PCA set before
the purge cycle.
• Vial and injector must be securely locked into the infuser
before beginning delivery.
PROGRAMMING
WARNING
FOR CUSTOM SYRINGES, CONFIRM THAT THE
DISPLAYED CONCENTRATION (MG/ML) OR (MCG/
ML) EXACTLY MATCHES THE CONCENTRATION
VALUE AND DRUG NAME ON THE SYRINGE. IF THEY
DO NOT MATCH, UNDER/OVERDOSAGE MAY
RESULT.
• In the CONTINUOUS and PCA+CONTINUOUS modes, if a
purge is not performed after a syringe change, the pump
automatically performs a small system compliance step
to remove slack when the
pressed (with door locked). Although fluid is not
normally delivered to the patient during the compliance
step, under some conditions up to 0.3 mL of fluid may be
delivered. If 0.3 mL of fluid represents a hazard to the
patient, the set should be disconnected during this
operation.
[START/PAUSE] key is
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LifeCare PCA 3 Infusion System 1- 11
• At flow rates less than 0.5 mL/hr, there may be a
significant delay before flow is established if system is
not purged.
• Selections are rounded up to the nearest tenth of a digit
for mg/mL values or to the nearest digit for mcg/mL
values.
LOADING DOSE/DOSE LIMITS
• A loading dose is included in the 4-hour (or 1) dose limit
calculation ONLY if administered after the 4-hour dose
limit has been programmed. If the loading dose is
administered prior to setting the 4-hour dose limit, it will
NOT be included in the 4-hour dose limit calculation. The
loading dose is always included in the total dose
delivered.
• A supplemental “booster” dose can be delivered at any
time during setup or operation, even if the 4-hour dose
limit is already reached or will be exceeded after delivery.
• Setting a new 4-hour dose limit will not erase the
previous 4-hour dose history.
• The concentration can only be changed by removing and
re-inserting a custom vial or by turning the pump OFF
then ON again. Once the concentration is programmed
and confirmed, it cannot be changed without performing
one of these two actions. If the concentration is
changed, the current settings and consequently the dose
limit accumulation are cleared.
• Partial boluses can be the result of interrupting delivery
by pressing [START/STOP] (PCA + Cont.), opening the
door (PCA Only), loss of power, reaching the dose limit,
emptying the vial, or a malfunction alarm.
• If the loading or supplemental “booster” dose causes the
4-hour dose limit to be exceeded, the complete dose will
still be delivered. The volume beyond the 4-hour dose
limit will count towards the “next” rolling 4-hour dose
limit.
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1- 12 1) Descriptive Information
• Always monitor the PCA 3 when delivering medication
with the door open.
• Patient Pendant is only to be pressed by the intended
patient.
OPERATION
• Perform close assessment and monitoring of patients
receiving potent analgesic medication for possible
adverse reactions.
• The PCA 3 is not intended to be used for frequent, long-
term portable operation. Keep plugged into a properly
grounded AC receptacle whenever possible, and reserve
battery power for temporary portable operation and
emergency backup. If the AC receptacle is in doubt, use
battery power.
MAINTENANCE
• Always confirm bar code reader window is clean. Blood,
fingerprints, condensation, and other elements may
obstruct the view of the bar code reader. Elements on the
window (other than scratches) can be cleaned by using
one of the recommended cleaning solutions in the
Section 7, Maintenance.
• Window scratches cannot be wiped clean and will
probably lead to window replacement.
• To avoid mechanical or electrical damage, do not
immerse the pump in any fluids or cleaning solutions.
• Some cleaning and sanitizing compounds may slowly
degrade components made from some plastic materials.
Using abrasive cleaners or cleaning solutions not
recommended by Hospira may result in product damage.
Do not use compounds containing combinations of
isopropyl alcohol and dimethyl benzyl ammonium
chloride.
• Do not sterilize by heat, steam, ETO, or radiation.
• Do not place the PCA 3 in service if it fails the self-test.
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LifeCare PCA 3 Infusion System 1- 13
• Hospira will be responsible for the effect on safety,
reliability, and performance of this device only if:
adjustments, modifications, or repairs are performed by
persons authorized by Hospira; the electrical setup at
the point of use complies with appropriate local
requirements; and the device is used in accordance with
the instructions for use identified in this operating
manual.
ALARMS
• If the MALFUNCTION alarm sounds, press the [ON/OFF]
key to turn the pump off. Then turn the pump back on. If
the malfunction alarm repeats, remove the pump from
service.
EPIDURAL ADMINISTRATION
• Recommended use of the epidural route is to provide
anesthesia or analgesia for periods up to 96 hours.
• It is strongly recommended that the epidural infusion
system be prominently identified as EPIDURAL. Failure
to identify the infusion system as epidural could result in
incorrect administration of intravenous rather than
epidural formulations. In addition, failure to identify the
epidural infusion system could result in confusion with
other infusion systems delivering concomitant
intravenous formulations.
• This device can be used to administer only those
anesthetics/analgesics approved for epidural
administration (as indicated or allowed by the drugs’
FDA approved labeling). Epidural administration of
drugs other than those indicated for epidural use could
result in serious injury to the patient.
• For epidural administration, the use of pump sets
without Y-sites, and "epidural" stickers indicating
ongoing epidural administration are recommended.
• Administration of drugs via the epidural route should be
limited to personnel familiar with associated techniques
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1- 14 1) Descriptive Information
and patient management problems. Proper epidural
placement of the catheter is essential since catheter
migration could result in intravascular or intrathecal
administration. Facilities practicing epidural
administration must be equipped with resuscitative
equipment, oxygen, naloxone, and other resuscitative
drugs. Adequate monitoring equipment (e.g., Oximetry)
is recommended for continuous monitoring of the
patient during epidural administration. Patients must be
observed frequently for side effects in a fully-equipped
and staffed environment for at least 24 hours following
completion of drug administration by the epidural route.
DELAYED RESPIRATORY DEPRESSION FOLLOWING
CONTINUOUS EPIDURAL ADMINISTRATION OF
PRESERVATIVE-FREE MORPHINE SULFATE HAS BEEN
REPORTED.
• The epidural space has 58 openings through which fluid
can exit. Pressure buildup during administration is
transient. However, if a large volume of fluid is
administered over a short time period, the pressure will
take longer to return to normal. If overdelivery occurs
during administration, observe the patient closely for
signs of spinal cord compression (disorientation,
headache, transient neuralgias) and drug overdose.
BATTERY OPERATION
WARNING
DISCONNECT AC POWER CORD BEFORE
REMOVING BATTERY DOOR.
CAUTION: D
BATTERY
MAINTAINED
OPERATION
O NOT OPERATE THE PCA 3 WITH THE
REMOVED ON PATIENTS. USE OF A PROPERLY
AND CHARGED BATTERY HELPS ENSURE PROPER
.
• The battery may not be fully charged upon receipt.
Connect the PCA 3 to AC power for at least 16 hours.
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LifeCare PCA 3 Infusion System 1- 15
• Use AC power whenever possible. Connect to AC power
during storage to ensure a fully charged battery for
emergencies.
• Always connect the pump to a properly grounded
receptacle unless battery operation is desired. If quality
earth grounding source is in doubt, use battery power.
• If the low-battery alarm sounds, connect to AC power
immediately.
SETS AND ACCESSORIES
Use Hospira Lifecare PCA Set List 6517 whenever the pump is in
CONTINUOUS or PCA+CONTINUOUS modes.
• When using PCA or PCA+CONTINUOUS mode, another
fluid line may be attached to the distal backcheck “Y”
site. Use Hospira Lifecare PCA Set, List 3559, 6516, or a
combination of List 6514 and 6517.
• It is recommended that highly viscous solutions and
drugs, colloidal suspensions and emulsions should not
be delivered through the inline backcheck valve of the
PCA set. Valve functionality may be compromised by the
presence of residue.
• Refer to vial and set package inserts for precautions and
information on proper handling.
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1- 16 1) Descriptive Information
NOTES
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LifeCare PCA 3 Infusion System 2- 1
2) Principles of Operation
The PCA 3 Infuser is a portable infusion pump that allows a
patient to self-administer analgesia within programmed limits as
well as providing continuous infusion of desired drug. Generally, a
nurse following a physician’s order programs the infuser with
operating parameters, which may include the following:
• Loading Dose
• Delivery Mode Setting, i.e., PCA, CONTINUOUS, or
PCA+CONTINUOUS
• PCA Dose
• Lockout Interval
• Rate of Continuous Flow
• 1 or 4 Hour Dose Limit (factory setting 4-hour)
• Protocols (Hospital configured settings for prefilled
vials)
Available operating parameters and their allowed ranges are
determined based on the confirmed vial and the delivery mode
selected. The loading dose and dose limits are optional. This
programmed flexibility allows the physician to tailor an effective
pain management program unique to each patient.
The PCA 3 can be programmed to deliver either PCA doses
(PCA mode), to deliver only a continuous background infusion
with no PCA doses permitted (CONTINUOUS mode), or to
deliver a continuous rate and allow PCA doses
(PCA+CONTINUOUS mode).
Analgesic drugs may be delivered through the PCA 3
intravenously by any of the three modes mentioned above. In
addition, Preservative-Free Morphine Sulfate Injection, USP, or
other approved analgesic drugs can be administered epidurally
through a recommended Low Priming Volume PCA Set without a
Y-adapter. The epidural route can be used to provide analgesia
by any of the three modes of infuser operation.
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2- 2 2) Principles of Operation
A “lockout” interval controls the frequency with which a patient
may receive a PCA dose of analgesic. If the pump is set in the
PCA or PCA+CONTINUOUS mode, the patient may request a
bolus of analgesic during therapy by pressing a button on the
patient pendant, causing the pump to release the specified bolus
of analgesic into the IV line. After a Loading or Supplemental
“booster” Dose delivery, the patient cannot receive any additional
patient requested boluses until the lockout interval has elapsed,
assuming the dose limit has not been exceeded (see Section 5.4
for a detailed description of Dose Limits).
The PCA 3 records therapy settings and up to 400 “events” that
may occur during the therapy regimen. Events recorded include
opening or closing of the security door, start or stop of continuous
infusion, an alarm condition, and so on. All event descriptions are
preceded with time of occurrence.
The PCA 3 operates on AC or back-up battery power. It attaches
and locks to an IV pole and also has a locking security door to
prevent tampering.
The alarm system sounds an audible alarm to alert the user to
various conditions or a malfunction (see Section 6.3 for a detailed
description of alarm messages).
2.1 Features
DRUG RECOGNITION
• Bar code reader identifies drug name and concentra-
tion in the vial (prefilled Hospira vials only)
• Bar code reader identifies custom-filled vials when
pharmacy-filled vial is used
MODES OF DELIVERY
• PCA Only
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LifeCare PCA 3 Infusion System 2- 3
• Continuous
• PCA + Continuous
PROGRAMMING
• Keypad with large numbers, decimal point & icons
for ease of use
• Prompting alphanumeric display
BATTERY
• 8 V Battery
• Long battery life (4 hours) for emergency backup and
temporary portable operation
BIO MEDICAL
• Serial Communication
• Upgradability (Field)
• Diagnostics Setup Options
• Alarm History
• Ability to store protocols for Hospira prefilled vials
OPTIONS
• Infusion History
OTHER FEATURES
• Microprocessor control
• Liquid crystal display (LCD) and Light-Emitting
Diode (LED) display
• Panel back illumination
• Security Features
• Prefilled and Sterile empty vials
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2- 4 2) Principles of Operation
2.2 Administration Equipment
The following sets and catheters are supplied sterile and are for
single use only.
ADMINISTRATION SETS
List 3559: PCA Set, Mini-Bore with Integral Anti-
Siphon Valve-SL 170 cm. Approximate
Priming Volume 2.3 mL. For use in PCA
mode via Intravenous route.
List 6514: PCA Extension Set with Backcheck Valve-
SL 25 cm. Approximate Priming Volume 1.1
mL. For use in conjunction with set 6517 to
convert from Continuous to PCA mode via
Intravenous route.
List 6516: PCA Set-Long, Mini-Bore with Integral
Anti-Siphon Valve-SL 218 cm. Approximate
Priming Volume 2.6 mL. For use in PCA
mode when extra length needed via
Intravenous route.
List 6517: PCA Continuous Infusion Set, Mini-Bore
with Integral Anti-Siphon Valve-SL 203 cm.
Approximate Priming Volume 1.5 mL.
For use in Continuous and
PCA+Continuous modes via Intravenous
route.
For use in PCA, Continuous, and
PCA+Continuous modes via Epidural
route.
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LifeCare PCA 3 Infusion System 2- 5
2.3 Printer Kits
List
12406-01:
List
12406-02:
** See current product sales catalog for available drugs **
Complete thermal printer kit includes:
printer, connector cable, battery pack, AC
adaptor, & paper pack.
Connector cable only
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2- 6 2) Principles of Operation
NOTES
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LifeCare PCA 3 Infusion System 3- 1
d
s
3) Equipment Description
3.1 Components
Security
Door
Vial
Cradle
Clips
Bar
code
Reader
Window
Injector
Vial
Cradle
Release
Mechanism
(Holder)
LED
Display
LCD
Display
Softkeys
Door
Lock
Keypa
Button
AC
Power
Indicator
Vial
Plunger
Basic Layout of Front Panel and Keypad
430-04684-002
Battery
Power
Indicator
3- 2 3) Equipment Description
Cradle
Release
Mechanism
Vial Base
Upper Vial
Retainer
Bar code
Reader
Window
(Vial Bar
code must
face)
Vial
Stopper
Vial Lip
Injector
Injector
Flange (Vial
Plunger)
Luer-Lock
Fitment
Vial Cradle
Clips
Vial Sensor
Switch
(Top Vial
Cradle
Clip)
Lower Vial
Retainer
(Middle
Bracket)
Injector
Flange
Retainer
Injector
Sensor
Switch
(Back of
Retainer)
Vial Cradle Assembly
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